Evaluation of NDV-3A Vaccine in Preventing S. Aureus Colonization

Completed · Phase 2 · Has a placebo group

Conditions studied: Staphylococcus Aureus

In brief

The proposed study aims to further evaluate the safety and immunogenicity of a candidate S. aureus vaccine NDV-3A, as well as its efficacy against acquisition of S. aureus

Key facts

Study ID

NCT03455309

Run by

NovaDigm Therapeutics, Inc.

People needed

382

Starts

2018-01-30

Expected to finish

2019-10-15

Last updated by the study team

2020-01-29

Who can join

Age: 17 and older, up to 35. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Active duty, male subject, 17-35 years of age, inclusive, at the time of screening.
• Assigned to one of the selected companies/battalions
• Informed of the nature of the study and has agreed to and is able to read, review, and sign the informed consent document prior to screening.
• Free of known significant health problems as established by the requirements to be enrolled in a military training program before entering into the study.
• Agrees to be reachable by phone, email or letter at 6 months post-vaccination.

You may not qualify if…

• Reports receiving any investigational drug, investigational vaccine, or investigational device within 30 days prior to dosing; subjects will be allowed to receive routine vaccinations associated with training and any other prescribed medications not in the exclusion criteria.
• Presence of clinically significant SSTI (e.g., cellulitis, abscess) at screening or other skin or skin structure infections that would confound the interpretation of clinical response.
• Reports a history of allergic response(s), anaphylaxis, or other serious reactions to previous vaccinations.
• Reports a history of allergies to yeast
• Reports a history of anaphylaxis or other serious reactions to aluminum.
• Reports a history of autoimmune disease (psoriasis, etc.)
• Seropositive for HIV antibody.
• Reports the use of any immunosuppressive drugs, including systemic corticosteroids (more than 14 days at a dose of >20 mg/day prednisone or equivalent), within 4 weeks prior to dosing.
• Reports receiving any blood products within 3 months prior to dosing.
• Reports donating blood/plasma within 28 days prior to dosing.
• Illness causing temperature ≥ 100.4°F
• Evidence of abnormal, unresolved laboratory results in the subject's medical record for the following tests: hemoglobin, white blood cell count, platelet count, creatinine, and alanine aminotransferase
• Any other medical and/or social reason which, in the opinion of the investigator(s), would increase the subject's risk of having an adverse reaction as a result of participation in the study.

Where it is running

• Fort Benning — Fort Benning, Georgia, United States

Full record on ClinicalTrials.gov

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